BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? ESOPHAGEAL

    MDR report key: 4213529 · Received October 30, 2014

    Report

    Report Number
    3005099803-2014-03543
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISPOSED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT.  THIS IS DEFINED AS A COMPLAINT THAT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED.    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.  A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT; HOWEVER, THE DISTAL END OF THE STENT FAILED TO EXPAND AND THE CATHETER WAS DIFFICULT TO REMOVE. IT WAS NOTED THAT THE STENT MOVED FROM ITS POSITION. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695577 WALLFLEX? ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516750 0017261478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention